So now they have revived and ramped up a political tactic from the late 1990's that already has been discredited, when Republicans and industry lobbyists unsuccessfully challenged EPA's 1997 smog and soot standards. (Query: where were Republican members of Congress with their indignation and assaults when the George W. Bush administration relied upon these same studies and science for 8 years?)

Congressman Lamar Smith (R-TX ) has vowed to subpoena EPA to seize confidential patient data underlying a subset of the medical studies showing this soot-death linkage. Smith took to the pages of the Wall Street Journal this week to level a fusillade of charges against EPA that was as notable for its cascade of misrepresentations and omitted facts, as it was for its vehemence.

In this post I will examine some of the facts you would never know from hearing just the politicized Republican view of soot pollution, as well as crucial information that these politicians are misrepresenting, selectively misquoting and ignoring.

Misrepresenting the Full Body of Scientific Evidence: Republican lawmakers pretend that the massive body of scientific evidence showing a causal association between soot pollution and mortality comes down to “secret” data from just two studies. This pretense is flat out false. The most basic investigation of public resources reveals a much broader body of scientific studies examining and reaffirming the causal association between fine soot pollution and mortality. These studies post-date the so-called "Harvard Six Cities" and "American Cancer Society" studies, some of them independently re-analyze the studies, and they consistently find the same causal soot-mortality relationship.

In revising and updating National Ambient Air Quality Standards (NAAQS) for fine particulate matter, EPA devotes an entire chapter of its Regulatory Impact Analysis (RIA) to cataloguing and reviewing updated health effects studies, and explaining how they were incorporated into the agency's 2012 standards review. See, e.g., here (at pp. 5-7 to 5-8 listing 5 updates from the proposed 2012 RIA; fig 5-4 at p. 5-73; pp. 5-31 to 5-35).

In 2009, Dr. C. Arden Pope published “Fine-Particulate Air Pollution and Life Expectancy in the United States,” reaffirming past studies and finding “improvements in life expectancy during the 1980s and 1990s were associated with reductions in fine-particulate pollution across the study areas, even after adjustment for various socioeconomic, demographic, and proxy variables.”

I could go on and on listing individual studies. But the first bullet above contains some of those studies for readers wishing to dive deeper than Congressman Smith has.

Misrepresenting Independent Scientific Reanalysis: Congressman Smith charges in his Wall Street Journal op-ed that the data in the Harvard and American Cancer Society studies “have not been subjected to scrutiny and analysis by independent scientists.” This is an especially outrageous falsehood.

As explained in a release by the esteemed Health Effects Institute, a contributor to the report, "[t]he 2010 [Global Burden of Disease report] was produced by a rigorous scientific process involving over 450 global experts and led by the Institute of Health Metrics and Evaluation (IHME) at the University of Washington along with its partner institutions: the World Health Organization, the University of Queensland, Australia, Johns Hopkins University, and Harvard University."

Similarly, in July 2000, the Health Effects Institute issued a special report entitled “Reanalysis of the Harvard Six Cities Study and the American Cancer Society Study of Particulate Air Pollution and Mortality.” The explicit goal of that study was “to conduct a rigorous and independent assessment of the findings of the Six Cities and ACS Studies of air pollution and mortality.” (p.ii) To accomplish this goal, the team of researchers had “access to the original data” once they entered into contractual agreements and a Memorandum of Understanding to ensure that confidentiality was protected. (p.4). The report concluded that “reanalyses assured the quality of the original data, replicated the original results, and tested those results against alternative risk models and analytic approaches” (pp.iii-iv).

EPA's Integrated Science Assessment for the PM2.5 standards explained (p. 7-95) that the Harvard and ACS studies have "undergone extensive independent reanalysis," and "were based on cohorts that were broadly representative of the U.S. population." Reviewing this assessment and the broader body of epidemiological and toxicological studies, EPA's official Clean Air Science Advisory Committee (CASAC) recommended “'upgrading' the causal classification for PM2.5 and total mortality to 'causal' for both the short-term and long-term time frames." CASAC further found "[t]here are epidemiological studies showing a positive association of all-cause mortality with PM2.5.”

A 2010 American Heart Association study, entitled "Particulate Matter Air Pollution and Cardiovascular Disease: An Update to the Scientific Statement From the American Heart Association," concluded that "intensive independent reanalyses corroborated the original findings of both [the Harvard and ACS] studies and resulted in innovative methodological contributions that demonstrated the robustness of the results to alternative modeling approaches." "Since 2004, there have been further reanalysis of both studies."

So even if the entire body of soot-mortality causation evidence did rest on the solid foundation of the Harvard and American Cancer Society studies—a cramped view that is demonstrably false—those studies have been independently and repeatedly reanalyzed and reaffirmed by other peer-reviewed scientific studies and initiatives.

Misrepresenting Views of the National Academy of Sciences: Congressman Smith's op-ed took further aim at the scientific data EPA has relied upon for its clean air health standards with this oblique, abbreviated claim: "The National Academy of Sciences declared in 2004 that the data EPA is using is of 'little use for decison-making.'"

This claim is immediately puzzling, since a more recent 2010 report from EPA's Science Advisory Board, which includes members of the Academy, concludes that the soot-related mortality "benefit estimates that EPA derives for [particulate matter] are based on two well-researched and highly respected cohort studies of air pollution health effects, the Harvard Six Cities Study and the American Cancer Study (ACS) Cancer Prevention Study. These are good foundations for the health benefits estimates for PM and these studies are supported by other recent studies and expert evidence gathered by the EPA project team."

The puzzle is cleared up by a must-read, devastating letter to Chairman Smith from Congresswoman Eddie Bernice Johnson (D-TX) that I will simply quote in relevant part:

This is a gross mis-characterization of what the National Academy of Sciences (NAS) report says. What is most remarkable about this mischaracterization is that you actually provided the original NAS document in one of your previous letters which you attached to the July 22 letter. The relevant sentence you purport to paraphrase reads in full:

"Although these cohorts have provided critical evidence for long-term effects, evidence from further follow-up of these two U.S. cohorts alone will have little use for decisionmaking." (emphasis added)

I assume that the mis-characterization in your July 22 letter is due to a misunderstanding between a research finding and a cohort. However, if this is a case of misunderstanding then it gives me great pause in considering the prospect of you and your staff receiving the underlying data being sought.

An especially intemperate July 22 letter from Congressman Smith to EPA Administrator Gina McCarthy repeats the selectively misquoted snippet above while continuing to ignore the broader body of supportive scientific studies. Then Congressman Smith's letter actually has the gall to accuse EPA of "practice[s] border[ing] on scientific misonduct" in his own missive that commits serial violations of scientific misconduct.

One could also add, as amply demonstrated above, that EPA is not relying upon these two cohorts or the Harvard and ACS studies alone in the agency's decionmaking or rulemakings.

Misrepresenting With Salacious “Secrecy” Charges: The Republican political campaign against clean air health standards has settled on a "secret data" talking point that owes more to an overarching, conspiratorial political narrative to characterize the current administration (think IRS, NSA) than it does to any truth. EPA has flat out rejected this secrecy charge:

The EPA is transparent with regard to the scientific bases of agency decision making and disagrees with assessments and your assertion that the agency relies on "secret" data in regulatory actions and of health benefits. In setting the National Ambient Air Quality Standards (NAAQS)in assessing health benefits anticipated from air pollution regulations, the EPA relies on the scientific studies that are published in the peer-reviewed literature. The EPA provides the information used in regulatory decisions, including the epidemiological studies, in the publicly available docket accompanying each rulemaking.

As EPA already has explained to Senator David Vitter (R-LA) in April and July, 2013 letters that Congressman Smith's office either is unaware of or ignores:

"The complete, linked set of data underlying these studies is held by the scientific researchers that conducted the relevant research, not the EPA."

"With regard to your request for the underlying raw data from the relevant studies, the EPA has requested from the relevant researchers the research data required to be provided under the Shelby Amendment, consistent with applicable protections for private medical and similar information. As indicated in the enclosed letters, this request has been made for the two remaining studies that are the subject of your request that are subject to the Shelby Amendment."

So why is Congressman Smith preparing to subpoena data from EPA that the agency does not have; that EPA has told Congress it does not have; and that the agency has requested from the researchers that do have the data? Who knows, but it's hard not to conclude that the House GOP subpoena enterprise is politically motivated and publicity-driven.

The truth is there is a basic difference between secrecy and confidential patient data subject to confidentiality agreements. The researchers and reanalysis initiatives that committed to the confidentiality policies of the relevant research institutions, as HEI and the GBD teams did, were able to access the data.

Others may suggest that these are efforts to supply outside parties with data that they otherwise could not obtain. I would also strongly object to obtaining this data for outside parties, who would not otherwise be given access to this sensitive data. That is not our job. ....

I am forced to question the scientific legitimacy of groups which cannot already obtain this data. They must not be legitimate scientists or must be untrustworthy with human research subject data, or they could simply apply to the American Cancer Society directly. I certainly don't think Congress should be obtaining confidential human research data to supply to outside groups that can't pass ethical muster, and I sincerely hope that is not the goal of this endeavor.

The Congresswoman's letter asks the simple question: "And for what purpose?"

It is noteworthy that industry attorneys challenging EPA’s various ambient air quality standards have not even bothered or deigned to waste words in their legal briefs on the salacious “secret data” charge because it is demonstrably false and lacks any legal weight. These highly capable industry attorneys know that EPA has more than enough studies, data and support in the publicly available rulemaking records to justify stronger clean air standards. And they are right, with federal courts upholding every one of EPA’s air quality standards in the face of industry lawsuits.

Some Congressional Republicans have chosen to manufacture a false political controversy over the clear scientific evidence, precisely because there is no serious legal or scientific dispute about the validity of the evidence.

Misrepresenting White House Statements: Congressman Smith’s op-ed also asserts that “President Obama's Office of Management and Budget recently acknowledged that ‘significant uncertainty remains’ about the EPA's claims based on its data sets, saying that the claims ‘may be misleading’ and should be treated with caution.” This misrepresentation rivals the outrageous falseness of the independent reanalysis claim.

The OMB report snippets quoted in the congressman’s op-ed were not directed at the causal association between fine soot pollution and mortality found in the Harvard and American Cancer Society studies. The passage from the OMB report (p.15) makes abundantly clear that the Congressman's selectively (mis)quoted characterizations of the report concerned entirely different issues: (1) “the ranges of benefits and costs” that OMB believed should be “treated with some caution”; and (2) “aggregating high and low-estimates” of benefits and costs that could “result in totals that may be misleading.”

I suspect EPA would readily admit the uncertainties associated with the ranges, high-end and low-end estimates of avoided premature deaths, along with other health endpoints and cost projections. But this is wildly different from charging that OMB agrees with contentions that the causal association between soot and death is itself uncertain or EPA’s findings are misleading. What is shockingly misleading, instead, is the way that Congressman Smith’s op-end misrepresents the OMB report.

And what of uncertainty? Scientists would be the first to acknowledge that uncertainty is a perennial feature of scientific inquiry and research. A 2002 National Research Council report, aptly entitled “Estimating the Public Health Benefits of Proposed Air Pollution Regulations,” makes the following sensible points that some politicians willfully ignore:

Even great uncertainty does not imply that action to promote or protect public health should be delayed. Decisions about whether to act, when to act, and how aggressively to act can only be made with some understanding of the likelihood and consequences of alternative courses of action. The potential for improving decisions through research must be balanced against the public health costs incurred because of a delay in the implementation of controls. Complete certainty is an unattainable ideal. (pp.126-127)

There is a common misperception that a high degree of certainty is required for regulatory actions to take place to protect public health. As a result, primary health benefits analyses that more fully and accurately portray the uncertainties might not be considered useful. It is unrealistic for EPA to defer decisions until it can make them on the basis of perfect science. A careful and deliberate balancing of the benefits and costs is required, and this balancing must be informed by a fair assessment of the current levels of uncertainty and a realistic evaluation of the likely reductions in uncertainty attainable through further research. (p.148)

So even the OMB report’s statements about uncertainty in benefit-cost totals and ranges must be understood in light of the NRC’s sensible commitment to public health.

Misrepresenting EPA’s Responsiveness to Congress: While this is more political theatrics than scientific insult, Congressman Smith’s recent letter to EPA attempts to paint the agency as unresponsive to legitimate congressional inquiries, by cataloguing a series of correspondence to which EPA allegedly has failed to respond. The problem with this, as Congresswoman Johnson’s letter points out, is that “EPA has responded on at least two occasions with detailed information pertaining to the studies you requested.” And EPA has respondedseparately to similar inquiries by Senator Vitter leading up to EPA Administrator Gina McCarthy’s confirmation. It’s one thing if those responses have not satisfied Congressman Smith; but it just seems petty and sensationalist to imply wrongly that the agency has not responded to earlier inquiries.

This is not new, this politicized campaign against clean air health safeguards founded on attacking and misrepresenting established science. As I wrote in a June 2012 blog post following a House committee hearing where I testified:

Rep. Joe Barton (R-TX), while noting helpfully that he was not a “medical doctor,” nonetheless asserted at a congressional hearing that there was no “medical negative” to mercury and soot pollution. He went on to claim that EPA’s numbers on premature deaths that the mercury and air toxics standards helped avoid were “pulled out of the thin air.” Unsurprisingly, real doctors at the American Lung Association, American Public Health Association and American Academy of Pediatrics wrote Barton expressing that they “were shocked at such statements.” [pdf]. These actual doctors responded to Barton’s outrageous statements as “professionals that treat patients who are impacted by lung, cardiovascular and neurological impairments” linked to air pollution. These doctors “see in the patients we treat what [] the scientific literature lets us know to expect: that air pollution makes people sick and cuts lives short.”

The doctors’ letter included an attachment listing dozens of studies showing the “medical negatives” from soot pollution, including premature death. To my knowledge, Congressman Barton never did respond to the doctors’ letter.

If Congress establishes the practice through legislation or subpoenas or political gamesmanship in which any American can expect their most private medical information to fall into the hands of lawyers and lobbyists and corporations or even the Internet, more thoughtful elected leaders will have to ask themselves how we are going to conduct these health studies in the future. Why would anyone sensibly participate in studies knowing that confidential patient data could become the play thing of politicians and industry?

As Congresswoman Johnson put it in her letter to Chairman Smith: "The truth is that there is no reason to warrant violating the trust of hundreds of thousands of American citizens who volunteered their personal information to make everybody's lives better."

About

Switchboard is the staff blog of the Natural Resources Defense Council, the nation’s most effective environmental group. For more about our work, including in-depth policy documents, action alerts and ways you can contribute, visit NRDC.org.